Perrigo Confirms That its Partner Synthon Has Filed for Generic Version of Xyzal(R) Solution and Announcement of Lawsuit by Sepracor/UCB
Press Release
Source: Perrigo Company
On Wednesday June 24, 2009, 10:29 am EDT
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Companies:Perrigo co.
ALLEGAN, Mich., June 24 /PRNewswire-FirstCall/ -- Perrigo Company (Nasdaq: PRGO; TASE) today announced that its partner Synthon Pharmaceuticals, Inc. has filed an Abbreviated New Drug Application (ANDA) for Levocetirizine solution 2.5mg/5ml, a generic version of Xyzal® solution 2.5mg/5ml. Under terms of an exclusive agreement between the companies, Perrigo has sales and marketing rights in Synthon's Levocetirizine products. The Company believes that Synthon is the first to file an ANDA with a Paragraph IV certification against Xyzal® solution that can entitle it to 180 days of generic exclusivity upon approval.
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{"s" : "prgo","k" : "c10,l10,p20,t10","o" : "","j" : ""} Xyzal® solution (Levocetirizine solution) 2.5mg/5ml is indicated for relief of symptoms associated with allergies and treatment of hives, and has sales of approximately $10 million annually, as measured by Wolters Kluwer Health for the quarter ending April 2009.
Synthon filed its ANDA for Levocetirizine solution 2.5 mg/5ml containing a Paragraph IV Certification with the U.S. Food & Drug Administration and notified UCB Inc., the New Drug Application holder for Xyzal® solution and Sepracor Inc., the listed patent owner, of its filing. On June 17, 2009, Sepracor and UCB filed suit alleging patent infringement in the United States District Court for the Eastern District of North Carolina against Synthon.
Perrigo's Chairman and CEO Joseph C. Papa stated, "This filing is another example of our investment in new products and expansion of our product portfolio. The first to file status also reflects Perrigo's continued focus on being first to market with new products. As always, Perrigo is committed to making quality healthcare more affordable for our customers." |
